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Ming Zhang, Oscar Lin
: Context .- Fine-needle aspiration of thyroid nodules is a reliable diagnostic method to determine the nature of thyroid nodules. Nonetheless, indeterminate cytology diagnoses remain a diagnostic challenge. The development of multiplex molecular techniques and the identification of genetic alterations associated with different follicular cell-derived cancers in the thyroid have led to the introduction of several commercially available tests. OBJECTIVE: - To summarize the most common commercially available molecular testing in thyroid cancer, focusing on the technical features and test performance validation...
August 24, 2016: Archives of Pathology & Laboratory Medicine
T Danielle Samulski, Virginia A LiVolsi, Lawrence Q Wong, Zubair Baloch
BACKGROUND: The gene expression classifier (GEC; Afirma-Veracyte) has proven to be an effective triage modality in the management of thyroid nodules. We evaluate our institutional experience with GEC, specifically examining performance as a first line testing strategy versus in conjunction with repeat fine needle aspiration (FNA), usage trends based on clinical setting, and performance related to diagnostic categories of The Bethesda System for Reporting Thyroid Cytology (TBSRTC). METHODS: All nodules undergoing GEC analysis from 1/2011 to 12/2015 at the Hospital of the University of Pennsylvania were identified using electronic database search methods...
November 2016: Diagnostic Cytopathology
Carmen V Villabona, Vineeth Mohan, Karla M Arce, Julia Diacovo, Alisha Aggarwal, Jessica Betancourt, Hassan Amer, Tessey Jose, Pascual DeSantis, Jose Cabral
INTRODUCTION: Thyroid nodules with fine needle aspiration (FNA) cytology categorized as atypia of undetermined significance(AUS) often undergo additional diagnostic analysis with the Afirma Gene Expression Classifier(GEC) which classifies these as either high probability of being benign(GEC-B) or suspicious for malignancy(GEC-S). Our goal was to assess the clinical validity and utility of GEC in the evaluation of AUS cytology and evaluate the performance of ultrasonography (USG) for predicting malignancy in this subset...
July 13, 2016: Endocrine Practice
Wendy L Sacks, Shikha Bose, Zachary S Zumsteg, Ronnie Wong, Stephen L Shiao, Glenn D Braunstein, Allen S Ho
BACKGROUND: The Afirma gene expression classifier (GEC) assesses malignancy risk in patients with indeterminate thyroid nodules. Afirma putatively reduces costs by classifying certain nodules as benign and thereby avoiding unnecessary surgery. Prior studies have evaluated its impact exclusively on GEC-tested nodules. The objective of the current study was to analyze the effect of Afirma on 1) cytopathology diagnosis, 2) the rate of surgery, and 3) the rate of malignancy on all indeterminate nodules at a high-volume thyroid center...
June 27, 2016: Cancer Cytopathology
Shweta Chaudhary, Yanjun Hou, Rulong Shen, Shveta Hooda, Zaibo Li
OBJECTIVE: The Afirma gene expression classifier (GEC) is a molecular test to further classify indeterminate fine-needle aspiration (FNA) as benign or suspicious for malignancy. STUDY DESIGN: A total of 158 FNAs with Bethesda category III/IV cytology were sent for an Afirma GEC test. We correlated the Afirma GEC results with surgical outcome and also compared the data after Afirma's implementation with the data before. RESULTS: Among the 158 FNAs, the Afirma result was benign in 63 (40%), suspicious in 85 (54%) and unsatisfactory in 10 (6%)...
2016: Acta Cytologica
Kristine S Wong, Trevor E Angell, Kyle C Strickland, Erik K Alexander, Edmund S Cibas, Jeffrey F Krane, Justine A Barletta
BACKGROUND: It is now recognized that noninvasive follicular variant of papillary thyroid carcinoma (NFVPTC) is a distinct subset of FVPTC with an exceedingly indolent clinical course. The Afirma gene-expression classifier (GEC) helps guide clinicians in the management of thyroid nodules with indeterminate fine-needle aspiration (FNA) results. Thyroid surgery is recommended for nodules with a suspicious Afirma result, whereas observation is deemed reasonable for most nodules with a benign result...
July 2016: Thyroid: Official Journal of the American Thyroid Association
Salem I Noureldine, Martha A Zeiger, Ralph P Tufano
No abstract text is available yet for this article.
August 1, 2016: JAMA Otolaryngology—Head & Neck Surgery
Jithma Prasad Abeykoon, Luke Mueller, Frank Dong, Ashish V Chintakuntlawar, Jonas Paludo, Rami Mortada
Thyroid nodules are classified into six cytological categories under the Bethesda classification system. Two of these categories, atypical of undetermined significance (AUS) and suspicious for a follicular neoplasm (SFN), are further labeled as "indeterminate" diagnosis. Starting in June, 2012, Kansas University-Wichita Endocrine clinic implemented Afirma® Gene Expression Classifier (AGEC) to evaluate the need for surgical resection of thyroid nodules in patients with an indeterminate diagnosis. Electronic medical records of patients who underwent thyroid nodule fine-needle aspiration from 2004-2014 were reviewed...
August 2016: Hormones & Cancer
Joseph Singer, John W Hanna, Jay Visaria, Tao Gu, Mark McCoy, Richard T Kloos
OBJECTIVES: The gene expression classifier (GEC, Afirma ) reclassifies as molecularly benign approximately one half of thyroid nodule fine-needle aspiration (FNA) biopsies with an initial indeterminate cytopathology diagnosis, facilitating clinical monitoring in lieu of diagnostic thyroid surgery. This study evaluated the long-term management patterns and thyroid surgery rates of GEC benign patients compared to a control group of cytopathology benign patients and also described the costs of thyroid surgery...
July 2016: Current Medical Research and Opinion
Pablo Valderrabano, Marino E Leon, Barbara A Centeno, Kristen J Otto, Laila Khazai, Judith C McCaffrey, Jeffery S Russell, Bryan McIver
OBJECTIVE: Several molecular marker tests are available to refine the diagnosis of thyroid nodules. Knowing the true prevalence of malignancy (PoM) within each cytological category is considered necessary to select the most appropriate test and to interpret results accurately. We describe our institutional PoM among cytological categories and report our experience with molecular markers. DESIGN: Single-center retrospective study. METHODS: We calculated the institutional PoM for each category of the Bethesda system (Bethesda) on all thyroid nodules with cytological evaluation from October 2008 to May 2014...
May 2016: European Journal of Endocrinology
N Paul Ohori, Karen E Schoedel
Recent advances in thyroid imaging, clinical evaluation, cytopathology, surgical pathology, and molecular diagnostics have contributed toward greater understanding of thyroid nodules. In particular, the development of the Bethesda System for Reporting Thyroid Cytopathology (BSRTC) has brought standardization to the field and the system dovetails well with the implementation of immunohistochemistry and molecular testing to diagnostic practice. Among the molecular strategies available, the application of the molecular panel of common genetic alterations can stratify indeterminate BSRTC diagnoses into low-risk and high-risk groups...
March 2014: Surgical Pathology Clinics
Jennifer A Sipos, Thomas C Blevins, Heidi Chamberlain Shea, Daniel S Duick, Shamsher K Lakhian, Brian E Michael, Michael J Thomas, Julie Ann Sosa
OBJECTIVE: The primary objective was to assess the operative rate in patients with a benign result from the Afirma gene expression classifier (GEC) during long-term follow-up at nonacademic medical facilities. The secondary endpoint of this study was the treating physician's opinion regarding the safety of GEC use compared to the hypothetical situation of providing thyroid nodule management without the GEC. METHODS: This was a retrospective study of nonacademic medical practices utilizing the GEC...
June 2016: Endocrine Practice
Prasanna Santhanam, Rodhan Khthir, Todd Gress, Ayman Elkadry, Omolola Olajide, Abid Yaqub, Henry Driscoll
Prior studies demonstrate that a novel genomic test, the gene expression classifier (GEC), could identify a benign gene expression signature in those nodules with indeterminate cytology with a negative predictive value of greater than 95 %. Examine the performance of the AFIRMA gene expression classifier in predicting benign and malignant nodules in patients with cytologically indeterminate nodules. MEDLINE and EMBASE search for studies meeting eligibility criteria between January 1, 2005, and August 30, 2015...
February 2016: Medical Oncology
Lindsay E Kuo, Rachel R Kelz
Preoperative diagnosis and operative planning for patients with thyroid nodules has improved over the last decade. The Bethesda criteria for cytopathologic classification of thyroid nodule aspirate has enhanced communication between pathologists and clinicians. Multiple genetic tests, including molecular markers and the Afirma gene expression classifier, have been developed and validated. The tests, along with clinical and radiologic information, are most useful in the setting of indeterminate cytology. The development of an updated diagnostic and treatment algorithm incorporating all available tests will help standardize the management of patients with nodular thyroid disease and reduce variation and inefficiencies in care...
January 2016: Surgical Oncology Clinics of North America
Betul Celik, Chantel R Whetsell, Aziza Nassar
BACKGROUND: Thyroid fine-needle aspiration (FNA) is used to assess appropriate management of nodular thyroid lesions safely, but Bethesda category III (atypia of undetermined significance/follicular lesion of undetermined significance) and category IV (follicular neoplasm/suspicious for follicular neoplasm) lesions are problematic. This study aimed to evaluate the Afirma Gene Expression Classifier (GEC) results for lesions in those categories. METHODS: Medical records of patients with thyroid FNA and GEC results were obtained from archived material...
December 2015: Diagnostic Cytopathology
Sung-Eun Yang, Peggy S Sullivan, Jianhua Zhang, Rekha Govind, Mary R Levin, Jian-Yu Rao, Neda A Moatamed
BACKGROUND: Thyroid fine-needle aspiration (FNA) plays a pivotal role in the evaluation of thyroid nodules. Up to 30% of cases are diagnosed as indeterminate by FNA, including atypia of undetermined significance, follicular lesion of undetermined significance, suspicious for a follicular neoplasm, and follicular neoplasm, with approximately two-thirds having a benign outcome. The gene expression classifier (GEC) test is a molecular test for cases with indeterminate cytology. The purpose of the current study was to examine the refining role of the GEC test within a single institution...
February 2016: Cancer Cytopathology
Qing-Li Zhu, William C Faquin, Anthony E Samir
OBJECTIVE: The purpose of this article is to investigate whether specific clinical and sonographic characteristics are predictive of a benign Afirma test result. MATERIALS AND METHODS: We conducted a retrospective study of Afirma gene expression classifier analysis performed in 44 patients with 45 indeterminate thyroid fine-needle aspiration (FNA) cytologic results between March 2013 and April 2014. Of these, 33 of 45 nodules (73.3%) were repeat atypia of undetermined significance (AUS) and follicular lesions of undetermined significance (FLUS), or follicular neoplasm (FN) and suspicious for a follicular neoplasm (SFN) before Afirma testing...
October 2015: AJR. American Journal of Roentgenology
Trevor E Angell, Mary C Frates, Marco Medici, Xiaoyun Liu, Norra Kwong, Edmund S Cibas, Matthew I Kim, Ellen Marqusee
CONTEXT: The Afirma gene expression classifier (GEC) is a molecular diagnostic test that has a high negative predictive value for ruling out malignancy in thyroid nodules with indeterminate cytology. Many patients with a cytologically indeterminate and GEC benign (Cyto-I/GEC-B) nodule undergo monitoring instead of diagnostic surgery, but few data describe their follow-up. OBJECTIVE: The objective of the study was to determine the sonographic changes and clinical outcomes for patients with Cyto-I/GEC-B nodules compared with patients with cytologically benign (Cyto-B) nodules...
November 2015: Journal of Clinical Endocrinology and Metabolism
Michiya Nishino
Advances in the molecular characterization of thyroid cancers have fueled the development of genetic and gene expression-based tests for thyroid fine-needle aspirations. Collectively, these tests are designed to improve the diagnostic certainty of thyroid cytology. This review summarizes the early published experience with the commercially available versions of these tests: the Afirma Gene Expression Classifier, ThyGenX (formerly miRInform)/ThyraMIR, and ThyroSeq. Key differences in testing approaches and issues regarding test performance and interpretation are also discussed...
January 2016: Cancer Cytopathology
Eran Brauner, Brittany J Holmes, Jeffrey F Krane, Michiya Nishino, David Zurakowski, James V Hennessey, William C Faquin, Sareh Parangi
BACKGROUND: The recently introduced Afirma gene expression classifier (AGEC) provides binary results (benign or suspicious) to guide management of cytologically indeterminate thyroid nodules. The AGEC is intended to reduce unnecessary surgeries for benign nodules, and management algorithms favor surgery for suspicious results. Limited data are available on the performance of this test for Hürthle cell nodules (HCNs). This study hypothesized that a predominance of Hürthle cells leads to an increased rate of suspicious AGEC results with a potential for overtreatment, despite a relatively low risk of malignancy...
July 2015: Thyroid: Official Journal of the American Thyroid Association
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